US2022280541A1PendingUtilityA1

Method for identifying carbohydrate drug-sensitive patient in patients having alzheimer's disease

Assignee: SHANGHAI GREEN VALLEY PHARMACEUTICAL CO LTDPriority: Aug 6, 2019Filed: Aug 5, 2020Published: Sep 8, 2022
Est. expiryAug 6, 2039(~13 yrs left)· nominal 20-yr term from priority
A61K 31/702G01N 33/6896G01N 1/30G01N 33/582C12Q 1/689C12Q 1/6869C12Q 2600/106A61P 25/28G01N 2800/2821G01N 33/56972G01N 33/6863A61K 49/0008C12Q 2600/112G01N 33/56911G01N 33/6806G01N 33/6848C12Q 1/6883G01N 2800/52C12Q 1/04
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Claims

Abstract

The present invention relates to identification of a carbohydrate drug-sensitive patient in patients having Alzheimer's disease. The present invention provides a method for identifying a carbohydrate drug-sensitive patient in patients having Alzheimer's disease.

Claims

exact text as granted — not AI-modified
1 . A method for identifying a carbohydrate drug-sensitive patient in patients having Alzheimer's disease, the method comprising:
 determining one or more of the following indicators in a sample from the patient and comparing them with corresponding reference indicators:
 (1) relative abundance of gut microbes; 
 (2) an amino acid level; 
 (3) a proportion of pro-inflammatory Th1 cells in CD4+ T cells; and 
 (4) a cytokine level; and 
   selecting the patients, whose measured indicators are substantially consistent with the reference indicators, as a carbohydrate drug-sensitive population.   
     
     
         2 . A kit for identifying a carbohydrate drug-sensitive patient in patients having Alzheimer's disease, the kit comprising:
 an agent for determining one or more of the following indicators in a sample from patients having Alzheimer's disease:
 (1) relative abundance of gut microbes; 
 (2) an amino acid level; 
 (3) a proportion of pro-inflammatory Th1 cells in CD4+ T cells; and 
 (4) a cytokine level. 
   
     
     
         3 . The method according to  claim 1 , wherein the determining of the one or more indicators is carried out by adding an agent to the sample from patients having Alzheimer's disease. 
     
     
         4 . A method for treating a patient having Alzheimer's disease, the method comprising:
 determining one or more of the following indicators in a sample from the patient and comparing them with corresponding reference indicators:
 (1) relative abundance of gut microbes; 
 (2) an amino acid level; 
 (3) a proportion of pro-inflammatory Th1 cells to CD4+ T cells; and 
 (4) a cytokine level; and 
   administering a pharmaceutical composition comprising a carbohydrate drug to the patient whose measured indicator is substantially consistent with the reference indicator.   
     
     
         5 . A method for identifying an individual who might have Alzheimer's disease, the method comprising:
 determining one or more of the following indicators in a sample from the patient and comparing them with corresponding reference indicators:   (1) relative abundance of gut microbes;   (2) an amino acid level;   (3) a proportion of pro-inflammatory Th1 cells in CD4+ T cells; and   (4) a cytokine level; and   identifying the individual, whose measured indicator is substantially consistent with the reference indicator, as the individual who might have Alzheimer's disease.   
     
     
         6 . The method according to  claim 5 , wherein the determining of the one or more indicators is carried out by adding an agent to the sample from the individual who might have Alzheimer's disease. 
     
     
         7 . The method according to  claim 4 , wherein the carbohydrate drug is selected from monosaccharides, disaccharides, oligosaccharides, polysaccharides, derivatives thereof, and a combination thereof. 
     
     
         8 . The method according to  claim 4 , wherein the sample is feces or peripheral blood. 
     
     
         9 . The method according to  claim 4 , wherein the gut microbes are one or more selected from Firmicutes, Bacteroidetes, Proteobacteria, Actinomycetes, Fusobacteria, Cyanobacteria, Verrucomicrobia, and a combination thereof. 
     
     
         10 . The method according to  claim 4 , wherein the amino acid is one or more selected from the following: 4-OH proline, acetylornithine, alanine, alpha-aminoadipic acid, asparagine, aspartic acid, asymmetric dimethylarginine, beta-alanine, carnosine, citrulline, creatinine, GABA, glutamic acid, glutamine, glycine, histidine, hypotaurine, isoleucine, kynurenine, leucine, lysine, methionine, methionine sulfoxide, ornithine, phenylalanine, pipecolic acid, proline, putrescine, pyroglutamic acid, serine, serotonin, taurine, threonine, tryptophan, tyrosine and valine. 
     
     
         11 . The method according to  claim 10 , wherein the level of one or more amino acids selected from the following is higher than the corresponding amino acid level in a corresponding normal subject: 4-OH proline, acetylornithine, alanine, alpha-aminoadipic acid, asparagine, aspartic acid, asymmetric dimethylarginine, beta-alanine, carnosine, citrulline, creatinine, GABA, glutamic acid, glutamine, glycine, histidine, hypotaurine, isoleucine, kynurenine, leucine, lysine, methionine, methionine sulfoxide, ornithine, phenylalanine, pipecolic acid, proline, putrescine, pyroglutamic acid, serine, serotonin, taurine, threonine, tryptophan, tyrosine and valine. 
     
     
         12 . The method according to  claim 4 , wherein the cytokine is one or more selected from the following: OPG, Resistin, TARC, VEGF, Chemerin, IL-9, MMP-2, VEGF-D, TCA-3, gp130, MMP-10, 6Ckine, VEGF-B, IL-22, IL-1a, IFNg R1, Granzyme B, LIX, CT-1, CD27L, Endoglin, TRANCE, MCSF, 4-1BB, Leptin R, CD36, TremL 1, VEGF R2, TGFb1, IL-3 Rb, and H60. 
     
     
         13 . The kit according to  claim 2 , further comprising:
 an instruction manual for instructing a user to compare the measurement result of the indicator in the sample with a corresponding reference indicator.   
     
     
         14 . The kit according to  claim 13 , wherein the instruction manual comprises the corresponding reference indicator. 
     
     
         15 . The kit according to  claim 13 , wherein the instruction manual is used to instruct the user to identify the patient as a carbohydrate drug-sensitive patient when the measurement result of the indicator in the sample is substantially consistent with the corresponding reference indicator. 
     
     
         16 . The method according to  claim 4 , wherein the carbohydrate drug is selected from mannuronic acid oligosaccharides. 
     
     
         17 . The method according to  claim 4 , wherein the amino acid is one or more selected from phenylalanine and/or isoleucine. 
     
     
         18 . The method according to  claim 17 , wherein the level of phenylalanine and/or isoleucine is higher than the corresponding amino acid level in a corresponding normal subject.

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